FDA.reportPublic FDA data

Philips Medical Systems

Matched from indexed company URL: Philips-Medical-Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96179783008581796PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.1N2026-01-01ADVANCED TECHNOLOGY CENTER MATAM BUILDING 34 HAIFA IL 3100202
30009765253000976525Philips Medical Systems Nederland B.V.1N2026-01-01High Tech Campus 36 Eindhoven Noord-Brabant NL 5656 AE
30037682513003768251Philips Medical Systems DMC GmbH1N2026-01-01Roentgenstrasse 24 HAMBURG DE 22335
30145417003014541700Philips Medical Systems Ltda1N2026-01-01Avenida Otto Selgado, 250 Varginha Minas Gerais BR CEP 37066
30145558053014555805Philips Medical Systems P.R. Inc.1Y2026-01-01Suite 512 Montehiedra Office Center 9615 Ave Los Romeros San Juan PR US 00926
30180048993018004899Philips Medical Systems (Cleveland), Inc.1N2026-01-013630 SW 47th Avenue Gainesville FL US 32608
30421758413042175841PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.1N2026-01-01VEENPLUIS 6 Best Noord-Brabant NL 5684 PC
19378501937850Philips Medical Systems1N2020-04-252039 Concourse Dr Saint Louis MO US 63146
96801943002807913PHILIPS MEDICAL SYSTEMS MR FINLAND1N2020-04-25AYRITIE 4 VANTAA Etela-Suomen laani FI 01510
30040223683004022368Philips Medical Systems (Cleveland), Inc.1N2020-04-255520 Nobel Dr FITCHBURG WI US 53711
30154428593015442859Philips Medical Systems (Cleveland) Inc.1N2020-04-25100 Park Avenue Suite 300 Orange Village OH US 44122

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00884838090699DigitalDiagnost C90 - The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes- Adjustable Straps for Patient Support;- Battery for SkyPlate E;- Compression Belt (singles. pull);- Hand grips (Pair of);- Infusion bottle holder;- Lateral cassette holder;- Mobile Detector Holder;- Paper roll holder;- Parking frame for accessories;- Patient Support for Stitching;- Remote control holder;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support+1(800)722-9377xx@xx.xx
00884838090705DigitalDiagnost C90 - The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes- Adjustable Straps for Patient Support;- Battery for SkyPlate E;- Compression Belt (singles. pull);- Hand grips (Pair of);- Infusion bottle holder;- Lateral cassette holder;- Mobile Detector Holder;- Paper roll holder;- Parking frame for accessories;- Patient Support for Stitching;- Remote control holder;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support+1(800)722-9377xx@xx.xx
00884838101456CombiDiagnost R90 - The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes- Adjustable Straps for Patient Support; - Adult headrest;- Ankle Clamps;- Arm Support;- Babix holder vertical stand;- Compression Belt (singles. pull);- Console trolles;- Detector Holder for Patient Bed;- Extra Stitching Ruler;- Hand grips (Pair of);- Handle;- Infusion bottle holder;- Leg Supports (Pair of);- Mattress GXR Systems;- Mobile Detector Holder;- Monitor Ceiling Suspension(Family);- Monitor CS for1 Monitor;- Monitor CS for2 Monitors;- Monitor CS for3 Monitors;- Monitor Trolley Family:- Monitor Trolley for 1 Monitor assembly;- Monitor Trolley for 2 Monitors assembly;- Patient Support for Stitching;- Rotable stool for footrest;- Shoulder supports (Pair of);- Side Bar;- Stretch Grip for VS/VM Stand+1(800)722-9377xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
12581069807376K993946PEGASYS ULTRALLZ2000-03-09
2426741069807376K993946PEGASYS ULTRALLZ2000-03-09
12461130667519K993923ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEMMUJ2000-04-07
2881001130667519K993923ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEMMUJ2000-04-07
12581036697622K992335BEACON-P, MODEL 211059KPS1999-10-07
2426741036697622K992335BEACON-P, MODEL 211059KPS1999-10-07
2426742010696512K992317AUTOSPECT PLUS WITH INSTILL MOTION CORRECTIONKPS1999-10-01
2426741993655324K992078VANTAGE EXSPECT IIKPS1999-09-01
12581961019751K991607VANTAGE 2.5KPS1999-07-26
2426741961019751K991607VANTAGE 2.5KPS1999-07-26
12581939847733K983948BEACON, MODEL 211060KPS1999-04-16
2426741939847733K983948BEACON, MODEL 211060KPS1999-04-16
12371128069375K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
12581944720132K982911FORTEKPS1998-11-16
2426741944720132K982911FORTEKPS1998-11-16
12371102766344K982795PHILIPS BUCKY VISIONMQB1998-11-24
12371221684535K982795PHILIPS BUCKY VISIONMQB1998-11-24
12581176610904K981291VANTAGE 3.0 INSYNCHKPS1998-06-29
2426741176610904K981291VANTAGE 3.0 INSYNCHKPS1998-06-29
12581459698759K9808673D-MSPECTKPS1998-06-04
2426741459698759K9808673D-MSPECTKPS1998-06-04
12581287294020K980715AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)KPS1998-05-06
2426741287294020K980715AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)KPS1998-05-06
2426741478104657K974513PINPOINTJAK1998-05-20
12581090972624K974474PEGASYS INTOUCHLLZ1998-02-24
2426741090972624K974474PEGASYS INTOUCHLLZ1998-02-24
12581939434747K973396QUEST PET IMAGING SYSTEMKPS1998-01-21
2426741939434747K973396QUEST PET IMAGING SYSTEMKPS1998-01-21
12581473595918K973233IMAGE FUSION AND REVIEW SYSTEMKPS1997-11-25
2426741473595918K973233IMAGE FUSION AND REVIEW SYSTEMKPS1997-11-25
12581188155278K971980MCD-ACKPS1997-10-23
2426741188155278K971980MCD-ACKPS1997-10-23
3204601595911040K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)DSI1998-03-23
12581786917280K971878VANTAGE 2.1 EXSPECTKPS1997-08-08
2426741786917280K971878VANTAGE 2.1 EXSPECTKPS1997-08-08
12371298466081K970640PHILIPS EASY DIAGNOSTIXR1997-03-21
12581833528571K964712PRISM XPVT SYSTEM (210823)KPS1997-02-21
2426741833528571K964712PRISM XPVT SYSTEM (210823)KPS1997-02-21
12371828905146K964124PHILIPS COMPUTED RADIOGRAPHYLLZ1996-12-18
2426741107697713K962010EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMSLLZ1997-03-21
2426741949209068K955268PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEMJAK1996-01-30
12581601624393K952684VERTEX EPIC MCDKPS1995-11-24
2426741601624393K952684VERTEX EPIC MCDKPS1995-11-24
12581624597113K952564INSPECT/PROSPECTKPS1995-11-22
2426741624597113K952564INSPECT/PROSPECTKPS1995-11-22
12461782432779K951581PINNACLE3 APEXIYE1996-04-08
2881001782432779K951581PINNACLE3 APEXIYE1996-04-08
12371451354209K951373FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQIXW1995-10-27
12371384747167K946320R 302KPW1995-05-11
12371496310898K945278PHILIPS BUCKY DIAGNOST FAMILYKPR1994-12-14
12581739141321K943623PQ5000 CT SYSTEMJAK1995-04-27
2426741739141321K943623PQ5000 CT SYSTEMJAK1995-04-27
2426741159903406K943596VANTAGE, FOR ADAC GAMMA CAMERASKPS1995-04-26
12371174301747K942481FUJI ULTIMA EC-MA CASSETTEIXA1994-07-29
865301688025296K936084OMNI WARM GEL PACKSIMD1994-03-31
12371084175368K933777CONCEPT ONEIZO1993-12-13
12371043275565K933650PHILIPS XRG 90 X-RAY GENERATOR SYSTEMIZO1993-10-07
12461735066541K926008PINNACLE 3IYE1994-10-04
2881001735066541K926008PINNACLE 3IYE1994-10-04
3204601506781566K905101NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFFDXQ1990-12-20
12581380726319K884268VOXELSCOPE(TM)JAK1988-12-20
2426741380726319K884268VOXELSCOPE(TM)JAK1988-12-20
12581406713958K873075ADAC MODEL ARC-5000, GAMMA CAMERAJWM1987-10-30
2426741406713958K873075ADAC MODEL ARC-5000, GAMMA CAMERAJWM1987-10-30
12581887031957K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ2026-05-27
12581596137549K253649Spectral CT Verida FamilyJAK2026-03-27
3445431881548544K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK2025-10-24
2183791211924612K251215Philips IntelliSpace CardiovascularLLZ2025-10-02
12581368217756K250648Philips iCT CT systemJAK2025-06-27
3204601501544618K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)MHX2025-09-02
12581224467713K244008Spectral CTJAK2025-05-16
2183791380672905K241659Ultrasound Workspace (UWS 6.0)QIH2025-02-10
12582018685888K240844Spectral CT 7500 RTJAK2024-10-18
12371415089414K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA2024-01-11
3445431241909007K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubDQK2024-03-14
12371765842423K233678Radiography 7000 MIZL2024-02-14
12371788957111K233662Radiography 7300 CKPR2024-06-13
12371315616371K232910CombiDiagnost R90JAA2023-10-19
3445431426558766K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubDQK2023-06-08
2183791177659823K213544TOMTEC-ARENAQIH2022-01-06
12581126087719K212875Spectral CT on RailsJAK2022-05-13
12371714820303K212837ProxiDiagnost N90JAA2021-09-21
12371808534816K212186Philips Radiology Smart AssistantKPR2021-12-13
12581994894882K211764Vereos PET/CTKPS2021-08-06
2183792000661369K211046eCareManager 4.5MSX2022-06-03
12581792462691K210880Vereos PET/CTKPS2021-05-19
12371944706471K210692DigitalDiagnostKPR2021-04-02
12371229650080K203087CombiDiagnost R90JAA2020-12-03
12371785372338K202564DigitalDiagnost C90MQB2020-09-30
3445431992464836K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterDQK2020-12-17
2183791988380984K200974QLAB Advanced Quantification SoftwareQIH2020-06-03
12581781529071K193454IQon Spectral CTJAK2020-01-24
2426741781529071K193454IQon Spectral CTJAK2020-01-24
2183792000658651K190913QLAB Advanced Quantification Software 13LLZ2019-06-18
12371328282187K182973DigitalDiagnost C90MQB2019-01-11
2183791424151033K181311Philips Hemodynamic Application R1.0MWI2018-09-07
2183791049533428K181264QLAB Advanced Quantification SoftwareLLZ2018-06-07
2183791151018245K180019CAAS WorkstationIZI2018-05-03
12371057308416K173433ProxiDiagnost N90OWB2018-02-05
2183791314221101K172609CSMC Cardiac SuiteKPS2017-11-03
12581739259078K172406Ingenuity TFKPS2017-10-06
2426741739259078K172406Ingenuity TFKPS2017-10-06
12581091718673K171850Philips CT Big BoreJAK2017-11-09
2426741091718673K171850Philips CT Big BoreJAK2017-11-09
12371390798174K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsMQB2017-07-07
3204601035116856K171423Nasal Alar SpO2 SensorDQA2017-07-27
2183791330096492K171314QLAB Advanced Quantification SoftwareLLZ2017-05-30
12371578323279K170113pixium 4343RCEMQB2017-02-09
12461750355423K170086Pinnacle Radiation Therapy Planning SystemMUJ2017-02-09
2881001750355423K170086Pinnacle Radiation Therapy Planning SystemMUJ2017-02-09
12581978554078K163711IQon Spectral CTJAK2017-04-05
2426741978554078K163711IQon Spectral CTJAK2017-04-05
12372010089703K163210Philips CombiDiagnost R90JAA2017-01-31
12582033651223K162838Philips iCT CT SystemJAK2017-04-07
2426742033651223K162838Philips iCT CT SystemJAK2017-04-07
12581602060175K160743Philips Ingenuity CTJAK2016-08-08
2426741602060175K160743Philips Ingenuity CTJAK2016-08-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS892021-08-06
JAK412026-03-27
LLZ282025-10-02
MQB132020-09-30
MUJ122026-05-27
DQA82017-07-27
JAA62024-01-11
KPR52024-06-13
DQK42025-10-24
MUE42013-12-13
LNH42011-03-22
IYE41996-04-08
QIH32025-02-10
OWB32018-02-05
IZL22024-02-14
MWI22018-09-07
IZI22018-05-03
HGM22014-11-25
OUO22011-11-23
MQM22001-03-19
DSI22000-05-17
IZO21993-12-13
JWM21987-10-30
MHX12025-09-02
MSX12022-06-03
OED12007-12-20
KXJ12005-03-25
OMJ12004-10-08
MPO12004-01-27
IXR11997-03-21
IXW11995-10-27
KPW11995-05-11
IXA11994-07-29
IMD11994-03-31
DXQ11990-12-20

PMA#

HeartStart OnSite Home Defibrillator

2022-03-20

PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS015 Date Received02/22/2022 Decision Date03/20/2022 Product Codes MKJ NSA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement...

HeartStart FRx Defibrillator

2022-03-20

Philips Medical Systems22100 Bothell Everett Hwybothell, WA 98021 PMA NumberP180028 Supplement NumberS012 Date Received02/22/2022 Decision Date03/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...

56 records. Showing 1-40. Next

PMN#

Spectral CT

2025-05-16

Philips Medical Systems Technologies , Ltd.

ROCC Console

2024-10-24

Philips Medical Systems Nederland B.V.

Zenition 90

2024-05-22

Philips Medical Systems Nederlands B.V.

Zenition 30

2024-02-16

Philips Medical Systems Nederland B.V.

MR 5300

2021-11-19

Philips Medical Systems Nederland B.V.

Zenition 70

2021-10-01

Philips Medical Systems Nederland BV

200 records. Showing 1-40. Next

GUDID#

DigitalDiagnost - The DigitalDiagnost is a high-end digital radiography system, that includes- Accessory-lead apron for Vertical stand;- Additional SkyPlate charger;- Adjustable Straps for Patient Support;- Compression Belt (singles. pull);- Detector Holder for Patient Bed;- Hand grips (Pair of);- Handle for Skyplate Large;- Infusion bottle holder;- Mobile Detector Holder;- Paper roll holder;- Patient Support for Stitching;- Portable Panel Protector;- Remote control holder;- Set of 50 Hygienic Bags large;- Set of 50 Hygienic Bags small;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2016-09-19

DigitalDiagnost - The DigitalDiagnost is a high-end digital radiography system, that includes- Accessory-lead apron for Vertical stand;- Additional SkyPlate charger;- Adjustable Straps for Patient Support;- Compression Belt (singles. pull);- Detector Holder for Patient Bed;- Hand grips (Pair of);- Handle for Skyplate Large;- Infusion bottle holder;- Mobile Detector Holder;- Paper roll holder;- Patient Support for Stitching;- Portable Panel Protector;- Remote control holder;- Set of 50 Hygienic Bags large;- Set of 50 Hygienic Bags small;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2016-09-19

DigitalDiagnost - The DigitalDiagnost is a high-end digital radiography system, that includes- Accessory-lead apron for Vertical stand;- Additional SkyPlate charger;- Adjustable Straps for Patient Support;- Compression Belt (singles. pull);- Detector Holder for Patient Bed;- Hand grips (Pair of);- Handle for Skyplate Large;- Infusion bottle holder;- Mobile Detector Holder;- Paper roll holder;- Patient Support for Stitching;- Portable Panel Protector;- Remote control holder;- Set of 50 Hygienic Bags large;- Set of 50 Hygienic Bags small;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2016-09-19

DigitalDiagnost C90 - The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes- Adjustable Straps for Patient Support;- Battery for SkyPlate E;- Compression Belt (singles. pull);- Hand grips (Pair of);- Infusion bottle holder;- Lateral cassette holder;- Mobile Detector Holder;- Paper roll holder;- Parking frame for accessories;- Patient Support for Stitching;- Remote control holder;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2019-03-28

DigitalDiagnost C90 - The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes- Adjustable Straps for Patient Support;- Battery for SkyPlate E;- Compression Belt (singles. pull);- Hand grips (Pair of);- Infusion bottle holder;- Lateral cassette holder;- Mobile Detector Holder;- Paper roll holder;- Parking frame for accessories;- Patient Support for Stitching;- Remote control holder;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2019-03-28

CombiDiagnost R90 - The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes- Adjustable Straps for Patient Support; - Adult headrest;- Ankle Clamps;- Arm Support;- Babix holder vertical stand;- Compression Belt (singles. pull);- Console trolles;- Detector Holder for Patient Bed;- Extra Stitching Ruler;- Hand grips (Pair of);- Handle;- Infusion bottle holder;- Leg Supports (Pair of);- Mattress GXR Systems;- Mobile Detector Holder;- Monitor Ceiling Suspension(Family);- Monitor CS for1 Monitor;- Monitor CS for2 Monitors;- Monitor CS for3 Monitors;- Monitor Trolley Family:- Monitor Trolley for 1 Monitor assembly;- Monitor Trolley for 2 Monitors assembly;- Patient Support for Stitching;- Rotable stool for footrest;- Shoulder supports (Pair of);- Side Bar;- Stretch Grip for VS/VM Stand

Philips Medical Systems DMC GmbH

2021-02-04

ProxiDiagnost N90 - The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes• Footrest• Hand GripsRadiation Protection Accessories• Flexible Radiation Protection Apron• Front Radiation Protection ApronAdditional Accessories (Optional)• Monitor Trolley• Monitor Ceiling Suspension• Parking Frame for Accessories• Shoulder Support• Side bar• Compression Belt• Adjustable Lateral Cassette Holder• Leg Supports• Infusion Bottle Holder• Arm Support for Catheterization• Ankle Clamps• Overhead Hand Grip• Adult Headrest• Mattress• Rotatable Stool for Footrest• Pediatric Micturition Set• Stretch Grip for Wall Stand• Bar Code Scanner• Patient Support• Stitching RulerAccessories for the SkyPlate Detector (Optional)• Mobile Detector Holder• Detector Holder Patient Bed• Portable Panel Protector• Detector Handle• WPD Bags• Grids for SkyPlate Detector large

Philips Medical Systems DMC GmbH

2022-01-17

Radiography 7300 C - Radiography 7300 C is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed Radiography 7300 C is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlate family can be used for free exposures as well as in the patient support table or in the vertical stand.The proposed Radiography 7300 C uses the following Accessories, • Parking frame for accessories• Handgrips• Side Bar• Adjustable straps• Compression Belt• Infusion Bottle holder TH-S• Infusion Bottle holder TH2• Support for CPR (Cardio Pulmonary Resuscitation)• Stretch Grip• Remote control holder• Charger 2EZ• Grid’s for Skyplayte Wireless Portable Detectors• Grid’s for Fixed Detectors• Detector Handle• Detector holder for patient bed• Mobile detector holder• Portable panel protector• WPD Hygienic bags• Patient support• Adjustable Straps for Patient Support• Stitching RulerRadiography 7300C is a successor of DigitalDiagnost C90 (Release Version 1.1). The main differences of Radiography 7300 C versus DigitalDiagnost C90 are optional new features:• Assisted collimation & Assisted detector height alignment (Smart Collimation Thorax / SCT)• Overlays including On-screen collimation & AEC Visualization

Philips Medical Systems DMC GmbH

2024-06-27

Radiography 7000 M - Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes:1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023)2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories3. Eleva WorkSpotIn addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed- Grid Landsc. SkyPlateE Large- Grid Landscape SkyPlate Large- Grid Portr. SkyPlate E Large- Grid Portrait SkyPlate Large- Grid Portrait SkyPlate Small- Handle for Skyplate Large- Portable Panel Protector- Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large)- Set of 50 WPD Hygienic Bags (small)

Philips Medical Systems DMC GmbH

2024-02-22

80 records. Showing 1-40. Next